- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04437082
Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography) (OCT)
September 13, 2021 updated by: Optovue
Performance Evaluation of OCT and OCTA-based Ocular Measurements
The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
143
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Tahlequah, Oklahoma, United States, 74464
- Oklahoma College of Optometry, Northeastern State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Seeing eye doctor for routine or follow-up care
Description
Inclusion Criteria:
- Normal - No pre-existing conditions.
- Glaucoma - Diagnosis of glaucoma.
- Retina - Diagnosis of retinal pathology
- Cornea - Diagnosis of clinic condition.
Exclusion Criteria:
- Unable to complete required exams.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal
no pre-existing conditions
|
imaging structural and vascular features of the eye
|
Glaucoma
diagnosis of glaucoma
|
imaging structural and vascular features of the eye
|
Retina
diagnosis of retina pathology
|
imaging structural and vascular features of the eye
|
Cornea
diagnosis of corneal condition
|
imaging structural and vascular features of the eye
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standard Deviation
Time Frame: Day 1
|
measure of variance
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2021
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
June 15, 2020
First Submitted That Met QC Criteria
June 17, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 200-54611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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